VYDUO (nebivolol hydrochloride) · PRINSTON INC
Nebivolol hydrochloride is a beta-adrenergic blocking agent indicated for the treatment of hypertension to lower blood pressure. It may be used as monotherapy or in combination with other antihypertensive agents. While specific controlled trials demonstrating cardiovascular risk reduction with nebivolol are not available, the reduction of blood pressure is clinically established to decrease the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
How VYDUO Works
The exact mechanism of action for nebivolol's antihypertensive response has not been definitively established. Possible contributing factors include decreased heart rate, reduced myocardial contractility, suppression of renin activity, and vasodilation resulting in decreased peripheral vascular resistance. Additionally, it may involve the diminution of tonic sympathetic outflow from cerebral vasomotor centers to the periphery.
Details
- Status
- Prescription
- First Approved
- 2022-09-19
- Routes
- ORAL
- Dosage Forms
- TABLET
VYDUO Approval History
What VYDUO Treats
3 indicationsVYDUO is approved for 3 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
VYDUO Competitive Set
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Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in VYDUO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications VYDUO treats. First-in-class if their pivotal trials read out positive.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VYDUO FDA Label Details
Indications & Usage
Nebivolol tablets are a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 1.1 Hypertension Nebivolol tablets are indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies ]. Nebivolol tablets may be used alone or in combination with other antihypertensive agents [see Drug Interactions ]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.